EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11298/2021 Rev. 0  
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance bifenazate in accordance with Regulation 
(EC) No  1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market, and amending the Annex to 
Commission I mplementing Regulation (EU) No 540/2011  
(Text with EEA relevance)   EN 2  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
renewing the approval of the active substance bifenazate in accordance with Regulation 
(EC) No 1107/2009 of the European Parliament and of the Council concerning the 
placing of plant protection products on the market, and amending the Annex to 
Commission Implementing Regulation (EU) No 540/2011  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1107/2009 , of the European Parliament and of the 
Council of 21 October 2009 concerning the placing of plant protection products on the market 
and repea ling Council Directives  79/11 7/EEC and 91/414/EEC1, and in particular 
Article  20(1)  (a) thereof,  
Whereas:  
(1) Commission Directive 2005/58/EC2 included  bifenazate  as an active substance in 
Annex I to Council Directive 91/414/EEC3. 
(2) Active substances included in  Annex I to Directive 91/414/EEC are deemed to have 
been approved under Regulation (EC) No 1107/2009 and are listed in Part  A of the 
Annex to Commission Implementing Regulation (EU) No  540/20114. 
(3) The approval of the active substance bifenazate , as set out in Part A of the Annex to 
Implementing Regulation (EU) No 540/2011  expires on 31 July 2022.  
(4) An application for the renewal of the approval of the active substance bifenazate  was 
submitted  to the Rapporteur Member State  in accordance with Artic le 1 of 
Commission Implementing Regulation (E U) No  844/20125 within the time period 
provided for in that Article.  
(5) The applicant submitted the supplementary dossiers required in accordance with 
Article  6 of Implementing Regulation (EU) No 844/2012. The application was found 
to be complete by the rapporteur Member State.  
                                                 
1 OJ L 309, 24.11.2009, p. 1.  
2 Commission Directive 2005/58/EC of 21 September 2005 amending Council Directive 91/414/EEC to 
include bifenazate and milbemectin as active substances  (OJ L 246, 22.9.2005, p. 17 ). 
3 Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on 
the market ( OJ L 230, 19.8.1991, p. 1).  
4 Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation 
(EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active 
substances (OJ L 153, 11.6.2011,  p. 1).  
5 Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the 
provisions necessary for the implementation of the renewal procedure for active substances, as provided 
for in Regulation (EC) No 1107/2009 of the European P arliament and of the Council concerning the 
placing of plant protection products on the market  (OJ L 252, 19.9.2012, p. 26 ). EN 3  EN (6) The rapporteur Member State prepared a  draft renewal assessment report in 
consultation with the co -rapporteur Member State and submitted it to the European 
Food Safety Authority ( ‘the Aut hority’) and the Commission on 29 January  2016 .  
(7) The Authority made the supplementary summary dossier available to the public. The 
Authority also circulated the draft renewal assessment report to the applicant and to 
the Member States for comments and launched a public consultation on it. The 
Authority forwarded the comments received to the Commission.  
(8) On 4 January 2017 , the Authority communicated  to the Commission its conclusion6 on 
whether bifenazate  can be expected to meet the approval criteria provi ded for in 
Article 4 of Regulation (EC) No 1107/2009 , where EFSA identified high risk to  birds, 
mammals and non -target arthropods for all representative uses and in addition , a high 
risk to operators and workers  for a majority of the representative uses . Furthermore, 
the risk assessment could not be finalised for aquatic organisms and consumers.   
(9) The Commission mandated EFSA in 17 November 2020  to assess  the risk when 
bifenazate is applied once a year using  the lowest dose presented in the dossier . The 
rapporteur Member State updated its draft Renewal Assessment Report accordingly and 
the Authority updated its conclusion on 30 August  20217 in which it identified a high 
risk to birds via long term exposure  to bifenazate for all representative uses . 
Furhte rmore, the consumer risk assessment could not be finalised . The Commission 
presented a renewal report regarding bifenazate to the Standing Committee on Plant s, 
Animals, Food and Feed  on 19 July 2017 and 22 October  2021 and a draft of this  
Regulation on 1 December  2021 .  
(10) The Commission invited the applicant to submit its comments on both conclusion s of 
the Authority  and, in accordance with the third paragraph of Article  14(1) of 
Implementing Regulation (EU) No 844/20128, on the renewal report. The applicant 
submitted its comments, which have been  carefully examined . 
(11) It has been established with respect to one or more representative uses of at least one 
plant protection product containing the active substance bifenazate t hat the approval 
criteria provided for in Article  4 of Regulation (EC) No  1107/2009 are satisfied.  
(12) It is therefore appropriate to renew the approval of bifenazate.  
(13) In accordance with Article  14(1) of Regulation (EC) No  1107/2009 in conjunction 
with Articl e 6 thereof and in the light of current scientific and technical knowledge, it 
is, however, necessary to provide for certain conditions and restrictions. It is, in 
particular, appropriate to restrict the use of plant protection products containing 
bifenaza te to non -edible crops in permanent greenhouses and to require further 
confirmatory information.  
(14) The restriction to use on non -edible crops will  exclude dietary exposure of consumers 
and is required since  the consumer risk assessment could not be finalised . As a high 
risk was identified to birds via long term exposure  to bifenazate , a restriction to use in 
                                                 
6 EFSA Journal 2017;15(1):4693. Available online: www.efsa.europa.eu . 
7 EFSA Updated peer  review of the pesticide risk assessment of the active substance bifenazate  EFSA 
Journal 2021;19(8):6818 . 
8 This Regulation was replaced by Regulation (EU)2020/1740 . However, it shall continue to apply to the 
procedure for the renewal of the approval of th e active substances: (1) whose approval period ends 
before 27 March 2024; (2) for which a Regulation, adopted in accordance with Article 17 of Regulation 
(EC) No 1107/2009 on or after 27 March 2021, extends the approval period t o 27 March 2024 or a later 
date. EN 4  EN greenhouses as defined in Article 3 of Regulation (EC) No 1107/2009 will ensure that 
birds are not  expos ed to bifenazate . In addition, as the Authority identified a high risk 
to mammals for some representative uses and a high chronic risk to bees based on the 
available data , the restriction to use only in greenhouses will also prevent exposure to 
those non -target organisms  as well as in drin king water .   
(15) As regards the criteria to identify endocrine disrupting properties introduced by 
Commission Regulation (EU) 2018/6059, on the basis of the available scientific 
information summarised in  the conclusion of the Authority, the Commission conside rs 
that bifenazate  is not to be considered as having endocrine disrupting properties.  
(16) In order to increase the confidence in the conclusion  that bifenazate  does not have 
endocrine disrupting properties , the applicant should provide an updated assessment , 
in accordance with point 2.2(b) of Annex II to Regulation (EC) No  1107/2009, of the 
criteria laid down in points 3.6.5 and 3.8.2 of  Annex II to Regulation (EC) 
No 1107/2009, and in accordance with the guidance for the identification of endocrine 
disruptor s10.  
(17) The risk assessment for the renewal of the approval of the active substance bifenazate 
is based on representative uses as an acaricide. In the light of this risk assessment, it is 
not necessary to maintain the restriction to use only as an acaricide.  
(18) Implementing Regulation (EU) No 540/2011 should therefore be amended 
accordingly . 
(19) Commission Implementing Regulation (EU) 745/202111 extended the approval period 
of bifenazate to 31 July 2021  in order to allow the renewal process to be completed 
before the expiry of the approval period of that active substance. However, given that 
a decision on renewal has been taken ahead of that extended expiry date, this 
Regulation shall apply as soon as possible.   
(20) The measures provided for in this Regulation are in accordance with the opinion of the  
Standing Committee on Plant s, Animals, Food and Feed , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Renewal of the approval of the active substance  
The approval of the active substance  bifenazate , as specified in Annex I,  is renewed subject to 
the conditions  and restrictions  laid down in that Annex.  
Article 2  
Amendments to Implementing Regulation (EU) No 540/2011  
The Annex to Implementing Regulation (EU) No 540/2011 is  amended in accordance with 
                                                 
9 Commission Regulation (EU) 2018/605 of 19 April 2018 amending  Annex II to Regulation (EC) 
No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties 
(OJ L 101, 20.4.2018, p.  33). 
10 ECHA (European Chemicals Agency) and EFSA (European Food Safety Authority) with the technical 
support of the Joint Research Centre (JRC), Andersson N, Arena M, Auteri D, Barmaz S, Grignard E, 
Kienzler A, Lepper P, Lostia AM, Munn S, Parra Morte JM, Pellizzato F, Tarazona  J, Terron A and 
Van der Linden S, 2018. Guidance for the identiﬁcation of endocrine disruptors in the context of 
Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311,135 pp.    
11 OJ L 160, 7.5.2021, p. 89 . EN 5  EN Annex II to this Regulation.  
Article 3  
Entry into force and date of application  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from 1 July 2022. 
This Regulation shall be bindin g in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN